Acute Outcomes With a Novel Plaque Modification System in Real-World Femoropopliteal Lesions.

PURPOSE: To report outcomes of a multicenter feasibility study using the FLEX Vessel Prep (VP) System, a novel technology that facilitates plaque incision and lumen gain in stenosed or occluded femoropopliteal arteries prior to balloon angioplasty. MATERIALS AND METHODS: Two hundred fifty-five patients (mean age 71.8±9.1 years) were treated with the FLEX VP System at 38 centers between December 2015 and November 2017. Average lesion length was 133±88 mm. Average baseline stenosis was 92%±11%; 112 (44.3%) of 253 patients presented with a chronic total occlusion. Conventional or drug-coated balloon (DCB) angioplasty was performed in all patients after vessel preparation. Vessel measurements were derived from angiograms acquired at baseline, after FLEX passage, and after subsequent ancillary procedures. Logistic regression analyses were performed to identify baseline or procedure variables that predicted the need for provisional stenting. RESULTS: Average percent reduction in vessel stenosis following treatment with the FLEX VP System was 27%±17%. No flow-limiting dissection, vessel perforation, or embolization was observed; 15 (5.9%) patients had minor (type A or B) dissections. Provisional stenting was performed in 49 (19.2%) patients. Average stenosis following angioplasty ± stenting was 9.1%±7.4%; 9 (3.6%) patients had significant residual stenosis ≥30%. Logistic regression analyses found that patients with dissections, longer lesions, and those receiving conventional balloon dilation alone were most likely to undergo stenting. CONCLUSION: In a real-world patient population with long, complex femoropopliteal lesions, use of the FLEX VP System as vessel preparation for angioplasty improved acute outcomes compared to historical controls. The rate of provisional stenting was low, and no serious vessel complications were observed.

Lower Extremity Revascularization Using Optical Coherence Tomography-Guided Directional Atherectomy: Final Results of the EValuatIon of the PantheriS OptIcal COherence Tomography ImagiNg Atherectomy System for Use in the Peripheral Vasculature (VISION) Study.

PURPOSE: To evaluate the safety and efficacy of a novel optical coherence tomography (OCT)-guided atherectomy catheter in treating patients with symptomatic femoropopliteal disease. METHODS: The VISION trial ( ClinicalTrials.gov identifier NCT01937351) was a single-arm, multicenter, global investigational device exemption study enrolling 158 subjects (mean age 67.2±10.5 years; 87 men) across 20 participating sites. In this cohort, 198 lesions were treated with an average length of 53±40 mm using the Pantheris catheter alone or Pantheris + adjunctive therapy. The primary safety endpoint was the composite of major adverse events (MAEs) through 6 months (objective performance goal 43.2%). Technical success (primary efficacy outcome) was defined as the percent of target lesions with a residual diameter stenosis ≤50% after treatment with the Pantheris device alone (objective performance goal 87.0%). Procedural success was defined as reduction in stenosis to ≤30% after Pantheris ± adjunctive therapy. Tissue specimens retrieved from each treated lesion were histologically analyzed to evaluate the accuracy and precision of OCT image guidance. RESULTS: The primary efficacy outcome was achieved in 192 (97.0%) of the 198 lesions treated with the Pantheris catheter. Across all lesions, mean diameter stenosis was reduced from 78.7%±15.1% at baseline to 30.3%±11.8% after Pantheris alone (p<0.001) and to 22.4%±9.9% after Pantheris ± adjunctive therapy (p<0.001). Of the 198 target lesions, 104 (52.5%) were treated with the Pantheris alone, 84 (42.4%) were treated with Pantheris + adjunctive angioplasty, and 10 (5.1%) with Pantheris + angioplasty + stenting. The composite MAE outcome through 6 months occurred in 25 (16.6%) of 151 subjects. There were no clinically significant perforations, 1 (0.5%) catheter-related dissection, 4 (2%) embolic events, and a 6.4% clinically driven target lesion revascularization rate at 6 months. The 40-lesion chronic total occlusion (CTO) subset (mean lesion length 82±38 mm) achieved a similar significant reduction in stenosis to 35.5%±13.6% after Pantheris alone (p<0.001). Histological analysis of atherectomy specimens confirmed <1% adventitia in 82.1% of the samples, highlighting the precision of OCT guidance. Characterization of the OCT-guided lesions revealed evidence of an underestimation of disease burden when using fluoroscopy. CONCLUSION: OCT-guided atherectomy for femoropopliteal disease is safe and effective. Additionally, the precision afforded by OCT guidance leads to greater removal of plaque during atherectomy while sparing the adventitia.

Reintervention after EVAR and open surgical repair of AAA: a 15-year experience.

OBJECTIVE: This study examined the frequency and reason for reinterventions and their impact on survival in contemporaneously treated cohorts of EVAR and open surgical repair (OSR) patients. BACKGROUND: EVAR has largely replaced OSR for anatomically appropriate AAA because of improved short-term outcomes. However, EVAR is associated with a notable reintervention rate. METHODS: Data for patients undergoing elective AAA repair between 1996 and 2011 were collected and analyzed to assess time from initial procedure to reintervention and rate of reintervention. Patient demographics, comorbidities, number and type of reinterventions, graft type, and timing of reintervention were analyzed. RESULTS: A total of 1144 patients underwent AAA repair; 558 had EVAR and 586 had OSR. In 76 EVAR patients, 123 reinterventions were performed; 46 reinterventions were performed in 30 OSR patients (P < 0.0001). Endoleak was responsible for 66% of EVAR reinterventions; colonic ischemia, bleeding, and incisional hernias caused 30%, 22%, and 22% of OSR reinterventions, respectively. Time to first reintervention was shorter in OSR patients (P < 0.001) and was related to AAA size (P < 0.001). Early reintervention at the index procedure in OSR patients had a 23% mortality rate. If reinterventions were not required, survival curves were similar. Current endografts require fewer reinterventions than earlier generation endografts. CONCLUSIONS: Reintervention was more common with EVAR and occurred later. Early reintervention after OSR is associated with significant mortality. If early reintervention in OSR patients can be avoided, there is no early survival advantage to EVAR. Current endografts require fewer reinterventions than earlier devices.

Final results of the Chronic Total Occlusion Crossing With the Ocelot System II (CONNECT II) study.

PURPOSE: To evaluate the safety and effectiveness of the optical coherence tomography-guided Ocelot catheter to cross femoropopliteal chronic total occlusions (CTOs). METHODS: The CONNECT II study was a prospective, multicenter, non-randomized single-arm study of the safety and effectiveness of the Ocelot catheter in CTO crossing. Key inclusion criteria were a 99% to 100% stenosed femoropopliteal segment, lesion length between 1 and 30 cm, and resistance to guidewire crossing. The main exclusion criterion was a severely calcified target vessel. The primary safety endpoint was 30-day major adverse events (MAE), while the primary effectiveness endpoint was successful CTO crossing (i.e., guidewire placement in the distal true lumen) with the Ocelot catheter. Endpoint analysis was based on pre-specified objective performance criteria. Between February and June 2012, 100 patients (55 men; mean age 69 years) were enrolled. Most of the CTOs (94%) were in the superficial femoral artery (SFA); mean lesion length was 16.6±9.3 cm. RESULTS: Through 30 days, 2 patients experienced MAE (significant perforations) related to the Ocelot catheter. The Ocelot catheter successfully crossed 97% of target CTOs either alone (72%), in conjunction with an assist device (18%), or in conjunction with a re-entry device (7%). Both primary safety and effectiveness endpoints were met. CONCLUSION: The Ocelot catheter with optical coherence tomography guidance offers physicians a reliable option for crossing femoral and popliteal chronic total occlusions with low MAE rates.

A multicenter experience evaluating chronic total occlusion crossing with the Wildcat catheter (the CONNECT study).

OBJECTIVE: Percutaneous techniques for crossing femoropopliteal chronic total occlusions (CTOs) offer an alternative to bypass surgery in patients deemed to be at increased risk due to advanced age or comorbidities. Recent reports document good success rates in catheters designed to reconstitute peripherally occluded arteries following failed guidewire passage. The Wildcat catheter (Avinger, Redwood City, Calif) is a novel device with a rotating distal tip and deployable wedges fashioned for channeling a passage through arterial occlusions. This report describes the results of a prospective, multicenter, nonrandomized trial evaluating the safety and efficacy of the Wildcat device when crossing de novo or restenotic femoropopliteal CTOs. METHODS: Between August 2010 and April 2011, patients with peripheral arterial disease due to a femoropopliteal CTO>1 cm and ≤35 cm were evaluated for study enrollment at 15 U.S. sites. During treatment, the physician initially attempted to cross the CTO using conventional guidewires per protocol; if the guidewire successfully crossed, the patient was considered a screen failure and the Wildcat was not deployed. At 30 days, patients were reevaluated. The primary efficacy end point was successful crossing of the Wildcat into the distal true lumen as confirmed by angiography. Primary safety end points included no in-hospital or 30-day major adverse events, no clinically significant perforation or embolization, and no grade C or greater dissection. Additional data collected included lesion length, degree of calcification, and location. RESULTS: Eighty-eight patients were enrolled in the trial. Of these, the Wildcat device was used in 84 patients (95%) per protocol. Successful CTO crossing was reported and confirmed by independent review in 89% (75/84) of cases with 5% (4/84) major adverse events as defined in the protocol (predominantly perforations sealed with balloon inflation). There were no clinically relevant events associated with any of the perforations. The mean CTO length was 174±96 mm (range, 15-350 mm). Approximately 57% (n=48) of all lesions were categorized as containing at least moderate calcification. Eighty-nine percent (n=75) of vessels recanalized were superficial femoral arteries. CONCLUSIONS: In this multicenter study, the Wildcat catheter demonstrated an 89% crossing success rate with little associated morbidity. The Wildcat catheter is a viable device for crossing moderately calcified femoropopliteal CTOs.

Heparin-induced thrombocytopenia after implantation of a heparin-bonded polytetrafluoroethylene lower extremity bypass graft: A case report and plan for management.

The proprietary heparin-bonded expanded polytetrafluoroethylene graft appears to be an attractive option for lower extremity revascularization in patients with compromised runoff and no autogenous vein. There is no detectable elution of heparin from the graft surface, but antithrombotic activity has been detected in devices implanted for >2 years. Although 15,000 Propaten (W. L. Gore and Associates, Flagstaff, Ariz) grafts have been implanted, to our knowledge, this is the first report of heparin-induced thrombocytopenia developing from this heparin-bonded graft. The heparin-induced thrombocytopenia responded promptly to graft explantation. A management plan is suggested for patients being considered for this graft.

Use of the abdominal aorta as an alternative access site for thoracic aortic stent graft placement.

The treatment of thoracic aortic pathology has undergone a paradigm shift in recent years, with a trend toward less invasive endovascular techniques and away from open surgical repair. Reports on the successful use of endografts in the thoracic aorta have demonstrated decreased morbidity and mortality of these procedures compared with traditional open repair. However, some patients are not candidates for an endovascular approach because of a short proximal landing zone, arch angulation, luminal irregularities, or a large diameter of the transverse arch and the proximal descending aorta. Other patients are excluded because of distal pathology or anatomic irregularities. This article presents 2 patients with thoracic aortic pathology, and both had inadequate proximal landing zones and small, calcified iliac arteries prohibiting femoral or iliac access. Successful repair of these patients was achieved by a staged procedure using a brachiocephalic debranching technique, followed by direct infrarenal aortic cannulation through a limited celiotomy.

Percutaneous venous valve bioprosthesis: initial observations.

Chronic deep venous insufficiency remains a major health problem in the United States and worldwide. Selected patients benefit from direct deep vein valve repair or valve transplantation; however, most are not candidates for these procedures. Experience with the bovine monocusp venous valve surgically inserted into the common femoral vein (CFV) demonstrates potential benefit and good long-term patency. A venous valve placed distal to the CFV via percutaneous access has great appeal and potential for further improving venous hemodynamics, as well as reducing ambulatory venous hypertension and ulceration. Two patients were treated with a percutaneous venous valve bioprosthesis as part of a Phase I trial. The primary objective was to evaluate the safety, patency, and efficacy of the percutaneous venous valve bioprosthesis to restore competency to the deep venous system.

Factors related to short length of stay after carotid endarterectomy.

In the past decade, expected in-hospital length of stay (LOS) after carotid endarterectomy (CEA) has decreased from 4 days to 1. Long LOS is associated with known complications and factors affecting severity of the patient's condition. Factors affecting an intermediate stay of 2 to 4 days need further clarification. The vascular registry at Jobst Vascular Center includes data on manifestation of disease; cardiovascular history; operation and discharge dates; surgeon; surgical details such as patching, shunting, and completion arteriography; and complications. Univariate chi-square and ANOVA and multivariate logistic regression were applied to analyze 635 CEAs performed in 1998, 1999, and 2000. Statistical significance was at a p value less than 0.05 (two-sided). Overall morbidity rate was 8.2% with three (0.5%) in-hospital neurologic complications and one death for a 0.16% mortality rate. Fifty-eight percent of the patients were discharged in 1 day. Patients staying 1 day were 3 years younger. Female gender and prior cerebrovascular accident were factors extending LOS to 2 and 3 days. History of angina, heart failure, valve disease, and vein patch or no patch contributed to LOS of 3 or 4 days. Completion arteriography had an association with LOS of 2 days. The relative percentage of patients with complications increased with LOS. No significant relationship was found for symptoms, smoking, myocardial infarction, atrial fibrillation, cardiac revascularization, or surgeon. Insulin-treated diabetes mellitus, cardiac risk factors, cerebrovascular accident, and vein patch or no patch correlated with prolonged hospitalization. Factors were identified that may alter a clinical pathway designed for discharge 1 day after CEA. Focused management of patients with cardiac and cerebrovascular accident history or requiring vein patch and a better understanding of CEA in women may further increase the percentage of patients discharged 1 day after CEA.

Crossing chronic total occlusions with the Ocelot system: the initial European experience.

AIMS: The aim of the study was to determine the safety, efficacy and feasibility of a new chronic total occlusion (CTO) device using optical coherence tomography (OCT) technology, the Ocelot catheter (Avinger, Inc., Redwood City, CA, USA), for crossing of SFA CTOs following guidewire failure. METHODS AND RESULTS: Prospective, multicentre, market preference testing. Thirty-three patients with confirmed CTO (99-100% stenosis by visual estimate) of their superficial femoral artery (SFA) were treated between September 28, 2011, and December 9, 2011, at three European centres. Ocelot crossed 94% (31/33) of CTOs, allowing guidewire placement in the distal true lumen. All (100%) lesions were treated without any major adverse safety events. Procedural time and contrast dose were significantly reduced (p<0.0001) when compared with a similar, non-OCT-guided CTO crossing device (Wildcat catheter; Avinger, Inc.). Overall physician feedback on the catheter performance was positive with an 87% average rating of excellent or good across seven categories. Performance ratings of Ocelot's OCT imaging guidance were consistently positive with an 86% average rating of excellent or good across five OCT categories. CONCLUSIONS: The Ocelot catheter combines advanced CTO crossing technology with real-time OCT guidance. When compared with a similar non-OCT-guided catheter, crossing efficacy and safety profile improved. Total procedure time and contrast volumes were significantly reduced. The Ocelot is a safe, efficient and effective tool for crossing CTOs.

Elective endovascular and open repair of abdominal aortic aneurysms in octogenarians.

OBJECTIVES: Endovascular aortic aneurysm repair (EVAR) is an increasingly popular treatment option for patients with abdominal aortic aneurysms (AAA), although open repair is considered the standard by virtue of its durability. Octogenarians, as a subgroup, may stand to benefit the most by EVAR. The purpose of this study is to review operative results and durability of open AAA repair and EVAR in octogenarians. METHODS: From May 1996 to August 2006, 150 patients aged >or=80 years underwent elective repair of their infrarenal AAA. Eighty-one underwent EVAR and 69 had open repair. Demographic data, aneurysm specifics, comorbidities, operative morbidity and mortality, intensive care unit and hospital length of stay, and late outcomes were analyzed. RESULTS: In the EVAR group, 27 of 81 (33%) patients died during a mean follow-up of 25 months. In the open repair group, 34 of 69 (49%) patients died during a mean follow-up of 43 months. The median survival time for EVAR was 350 weeks (range, 145-404 weeks) compared with 317 weeks (range, 233-342 weeks) for the open repair group. A Kaplan-Meier log-rank analysis showed no difference in early or long-term survival between EVAR and open repair (P = .13). EVAR was associated with decreased blood loss, decreased length of intensive care unit and hospital stays, and a greater number of patients discharged to home. CONCLUSIONS: EVAR and open repair are comparable in safety and efficacy in octogenarians. Operative repair outcomes remain acceptable. Mid- and long-term survival are similar, indicating no survival advantage of one procedure compared with the other.

Elective treatment of abdominal aortic aneurysm with endovascular or open repair: the first decade.

OBJECTIVES: The development of endovascular aneurysm repair (EVAR) as an alternative to open repair of abdominal aortic aneurysms (AAA) has led to an increasing number of patients being treated by this less-invasive technique. It was anticipated that EVAR would reduce the operative mortality and morbidity compared with open repair. This study examined the initial 10-year experience in one center when both techniques were available to determine if there were advantages to one technique or the other, putting the results into the perspective of routine clinical care of patients with infrarenal AAA. METHODS: From June 1996 to May 2005, 677 patients underwent elective repair of their infrarenal AAA, of which 417 were treated with open repair and 260 by EVAR. Demographic and aneurysm-specific data, comorbidities, operative morbidity, mortality, and late outcome were analyzed. RESULTS: Open repair patients were 2 years younger (71 vs 74 years, P < .001), had larger aneurysms (6.01 +/- 1.38 cm vs 5.45 +/- 0.99 cm, P < .001), greater familial predisposition, a higher incidence of current smokers, and a higher incidence of chronic obstructive pulmonary disease than the EVAR group. There were no differences in renal function, hypertension, coronary artery disease, or heart failure between the two groups. Overall operative mortality was 3.1%; operative mortality per group was 3.5% for open and 2.7% for EVAR (P = .627). Procedure-related outcomes showed significant differences in operative blood loss and length of hospital stay in favor of EVAR, and 95% of the EVAR patients were discharged home vs 83% in the open repair group (P < .001). A Kaplan-Meier log-rank analysis showed no difference in early or long-term survival between open repair and EVAR (P = .20), but did show a difference in mid-term (3-year) survival favoring open repair (P < .002). Survival analysis by age (<70 and > or =70 years) showed no difference between treatment groups. CONCLUSIONS: Open repair and EVAR are both performed safely in patients treated for elective infrarenal AAA. EVAR has the perioperative advantages of reduced blood loss, reduced length of intensive care unit and hospital stay, and increased number of patients discharged to home. The mid-term survival advantage of open repair has been observed in other reports and deserves further study.

Endoluminal embolization and revascularization for complicated mesenteric pseudoaneurysms: a report of two cases and a literature review.

Mesenteric artery pseudoaneurysms are a rare and complex complication after abdominal trauma, surgery, or inflammatory disease. These lesions can be associated with compression or erosion into adjacent structures and may result in life-threatening hemorrhage. Traditional management has been open surgical ligation, aneurysm resection with interposition grafts, or resection or partial resection of the end organ involved. We present two cases of endovascular repair of complex mesenteric pseudoaneurysms. One patient presented with a recurrent pseudoaneurysm of the superior mesenteric artery and the second presented as recurrent gastrointestinal bleeding secondary to a traumatic celiac artery pseudoaneurysm-to-pancreatic duct fistula. A systematic review of the literature on endovascular management of mesenteric vascular disease and mesenteric pseudoaneurysms is included in this report to allow these cases to be put into proper perspective.

Carotid artery velocity characteristics after carotid artery angioplasty and stenting.

OBJECTIVE: Correlation of carotid duplex ultrasound (DUS) flow velocities with carotid artery stenosis before and after carotid endarterectomy is well established. With the evolution of catheter-based techniques, carotid stenosis increasingly is being treated with angioplasty and stenting (CAS). CAS changes the physical properties of the arterial wall, which may alter blood flow velocities compared with the nonstented carotid. Opinions differ about whether DUS is a reliable tool to assess technical outcome and recurrent stenosis after CAS. This study correlated carotid DUS flow velocity findings with carotid arteriography after CAS. METHODS: Data from 77 pairs of carotid arteriograms with corresponding DUS after CAS in 68 patients were reviewed. Preintervention and postintervention DUS and carotid arteriogram data were evaluated for each patient. Peak systolic velocities (PSV), end-diastolic velocities (EDV), and internal carotid artery/common carotid artery ratios (ICA/CCA) were correlated with the post-CAS arteriogram. RESULTS: The mean preintervention PSV was 390 +/- 110 cm/s (range, 216 to 691 cm/s), and the average EDV was 134 +/- 51 cm/s (range, 35 to 314 cm/s). Postintervention DUS was obtained a mean of 5 days after CAS (range, 1 to 30 days). Sixty (81%) post-CAS arteriograms were normal, and each corresponded to a normal postintervention DUS (PSV range, 30 to 118 cm/s; EDV range, 18 to 60 cm/s). In 14 arteries (19%), completion arteriograms revealed residual stenoses of 20% to 40% in 13, and 50% in one. The mean PSV was 175 cm/s (range, 137 to 195 cm/s), and the mean EDV was 44 cm/s (range, 20 to 62 cm/s). All velocities exceeded the threshold of a 50% stenosis by DUS criteria for a nonstented carotid artery. In three arteries (2 patients), high-grade recurrent stenoses detected by DUS developed that required reintervention during follow-up. This high-grade restenosis was confirmed by arteriography in each patient, providing an additional three correlations. CONCLUSIONS: Normal DUS imaging reliably identifies arteriographically normal carotid arteries after CAS. Carotid velocities are disproportionately elevated with mild and moderate degrees of stenoses, and velocity criteria for quantitating stenoses in these patients require modification. However, DUS appropriately identifies severe recurrent stenoses after CAS.

Internal iliac artery occlusion using a stent-graft tunnel during endovascular aneurysm repair: a new alternative to coil embolization.

PURPOSE: To report a new endovascular technique for internal iliac artery (IIA) occlusion during stent-graft treatment in patients with aortoiliac aneurysm. TECHNIQUE: Stent-grafts measuring 20 to 28 mm in diameter and 37.5 mm long were deployed at the iliac bifurcation to occlude the IIA at its origin. Subsequent deployment of an aortic bifurcation endograft with ipsilateral extension into the external iliac artery was through this iliac stent-graft tunnel. This approach has been used in 5 patients with abdominal aortic aneurysm and common iliac artery aneurysm (n=4) or isolated iliac artery aneurysm. Proximal IIA occlusion was achieved in all cases with no distal type I endoleak. IIA patency on the side opposite to the tunnel procedure was preserved in each case. No patient described new onset of pelvic ischemic symptoms. Over a mean 10-month follow-up (range 1-12), there was no secondary procedure required for type I endoleak. Three patients had a CIA aneurysm diameter change of -1, -4, and 0 mm at 1 year. CONCLUSIONS: This new method for IIA occlusion at its origin without coil embolization may prove to be a useful adjunct to endovascular aortoiliac aneurysm repair. The technique is simple, rapid, and may minimize the risk of pelvic ischemia.

Distal internal iliac artery embolization: a procedure to avoid.

OBJECTIVES: Internal iliac artery (IIA) coil embolization as an adjunct to endovascular stent grafting (ESG) is common practice for treating abdominal aortic aneurysm (AAA) in patients with a substantially enlarged common iliac artery requiring extension of the stent-graft limb into the external iliac artery. The literature describing pelvic ischemia in association with IIA coil embolization contains conflicting reports of symptom severity. We studied IIA occlusion outcome as a function of coil placement in the IIA. METHODS: From August 1997 to March 2002, 20 patients with AAA underwent ESG with unilateral IIA coil embolization. Coils were placed proximal to the first branch of the IIA in 8 patients and distal to the first branch in 12 patients. Symptoms of pelvic ischemia and mid-term outcome were studied. RESULTS: Patients included 18 men and 2 women with mean age of 70(1/2) years (range, 53-86 years). Mean diameter of AAA was 54.4 mm (range, 38-80 mm), and of common iliac artery was 24.2 mm (range, 15-48 mm). Ten patients (50%) had new onset of symptoms of pelvic ischemia after endograft procedures: 1 of 8 patients (13%) with proximal IIA embolization had buttock claudication, and 9 of 12 patients (75%) with distal IIA embolization had pelvic ischemic symptoms, including buttock claudication in 8 and impotence in 1 (P =.02, Fisher exact test). No colonic ischemia occurred in this series. At 12-month follow-up, 4 patients with distal IIA embolization were symptom-free. At further follow-up to 24 months, 4 patients remained significantly limited with symptoms of claudication. CONCLUSIONS: A significantly higher incidence of symptoms of pelvic ischemia occurred with more distal placement of coils for IIA embolization. Failure to control for extent of coil placement may account for the apparently conflicting results in published studies. IIA coil embolization should be performed as proximal as possible to prevent interference with pelvic collateral circulation.

Bell-bottom aortoiliac endografts: an alternative that preserves pelvic blood flow.

OBJECTIVE: Dilated common iliac arteries that complicate aortic aneurysm stent grafting usually have been managed with endograft extension across the iliac artery bifurcation with internal iliac artery (IIA) occlusion. We studied 25 patients with significant common iliac artery (CIA) dilation treated with two methods: endograft extension across the iliac bifurcation or a new approach with a flared cuff within the CIA that preserves the IIA. METHODS: Of 86 patients with abdominal aortic aneurysm (AAA) who underwent bifurcated endovascular stent grafting (ESG), 25 (29.1%) had at least one dilated CIA. Two treatment groups had different methods of management of iliac artery dilation. Group 1 underwent ESG with straight extension across the iliac bifurcation and IIA coil embolization before the ESG procedure (n = 2) or simultaneously with ESG (n = 8). Group 2 underwent ESG with flared distal cuff (AneuRx, Medtronic AVE, Santa Rosa, Calif) contained within the CIA, the so-called "bell-bottom" procedure, thus preserving the IIA (n = 15). Iliac artery dimensions, operating room time, fluoroscopy time, and postoperative complications were prospectively gathered. RESULTS: Two women and 23 men had mean diameters of AAA of 56.6 mm (range, 38 to 98 mm) and of CIA of 21.4 mm (range, 15 to 48 mm). The diameters of CIA treated with device extension into external iliac artery after IIA coil embolization in group 1 and with the bell-bottom procedure in group 2 were not different (mean CIA diameter, 19.9 mm; range, 15 to 26 mm; and mean, 19.1 mm; range, 15 to 24 mm; respectively). However, significantly lower operating room and catheter procedure times were found in group 2 compared with group 1 (137 versus 192 minutes; 58 versus 106 minutes; P =.02 and.02, respectively). No periprocedural type I endoleaks were found in either group. Nine patients in group 2 also had a second contralateral CIA aneurysm, and five patients (mean CIA diameter, 33.0 mm; range, 22 to 48 mm) underwent treatment with extension across the iliac artery bifurcation and IIA occlusion. Use of the bell-bottom procedure on the other side allowed preservation of one IIA. Four cases (mean diameter, 19.3 mm) also underwent contralateral bell-bottom procedure. Two of these group 2 patients had complications, with severe buttock claudication in one and distal embolism necessitating limb salvage bypass after preoperative coil embolization of the IIA in another. CONCLUSION: Significant CIA ectasia or small aneurysm is often associated with AAA. In such cases, the bell-bottom procedure that preserves IIA circulation is a new alternative to the common practice of placement of endograft extensions across the iliac artery bifurcation in patients with at least one CIA diameter of less than 26 mm. Additional benefits include reduced total procedure time. Early technical success appears to justify continued use. However, long-term evaluation is necessary to determine durability because the risk of rupture as the result of potential expansion of the excluded iliac artery or late failure is unknown.